On the other hand, if the disease is more peripheral, local corticosteroid injections and sulfasalazine were recommended as an alternative to TNFi.
Both panels strongly advocated against the use of long-term systemic glucocorticoids in patients with axSpA. Both panels agreed that total hip arthroplasty should be considered in patients with refractory pain or disability and radiographic evidence of structural damage. Clinical outcomes, e. There are no studies to address the benefits of routine monitoring, which show improved patient outcomes, so neither body of recommendation commented on the frequency of monitoring.
MRI continues to be expensive, and there is currently no established benefit of treating residual inflammation on MRI in an asymptomatic individual. Regarding X-rays, it has not been shown yet clearly and without doubt that the therapeutic reduction of disease activity has an influence on structural damage of the SI joints and the spine visible on X-rays.
Therefore, neither MRI nor X-ray was preferred modality to monitor disease activity. They developed different sets of questions for AS, nr-axSpA, and extraarticular manifestations see Figs. Active disease was defined as symptoms at an unacceptably bothersome level as reported by the patient, and judged by the examining clinician to be due to axSpA. Stable disease is that which causes symptoms that are bothersome but at an acceptable level as reported by the patient.
The decision of escalation of therapy was based on these clinical parameters.
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On the other hand, the ASAS-EULAR committee developed a step-up approach, where they mentioned the explicit conditions in which biologic agents should be started, continued, switched, and tapered. This implies that a treatment algorithm including escalation steps is guided by measuring disease activity with the aim to reach clinical remission or, if not possible, a status of low disease activity.
This was based on the rationale that high disease activity leads to new syndesmophyte formation in patients with axSpA, 76 thus underscoring the importance to achieve remission or low disease activity. Furthermore, it was postulated that attainment of a symptom-free state, which is always an important therapeutic aim, can better be reached if treating physicians are guided by measuring disease activity target.
Table It is relevant to identify predictors before start of treatment, which are able to identify patients that will have a beneficial response to biologic therapy in axSpA patients, especially considering the economic burden and potential side effects of these agents.
Although the majority of AS patients respond very well to TNF-blocking therapy, a significant proportion of patients have to withdraw from treatment because of inefficacy or adverse events. The presence of inflammation at baseline was found to be an important independent predictor of achieving response to TNF-blocking therapy in almost all studies in AS patients. Until now, no biomarker or a set of biomarkers have been found to predict clearly the response to TNFi.
For evaluating TNFi, not only the response regarding disease activity but also the effect on disease-related quality of life and radiographic outcome is important.
Their combined use enables adequate prediction of outcome resulting from anti-TNF and conventional therapy in various AS subpopulations. How do we clinically assess patients with axSpA rigorously in clinical trials? These include the domains of physical function, pain, spinal mobility, patient global assessment, morning stiffness, fatigue, peripheral joints and entheses, and acute phase reactants.
The patient questions in these composite measures ask about severity of the disease in relation to many of the items in the ASAS-OMERACT core set, including physical function and pain, both in the axial spine and periphery. Quantitative thresholds of disease severity have been defined, e. Because axSpA can cause impaired mobility, e. Specific measures for clinical domains such as enthesitis have been developed and are utilized in clinical trials to document changes in this domain.
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Newer measures which assess both quality of life and function, such as the ASAS Health Index, have been rigorously developed based on input from patient focus groups, guidance from psychometricians, and testing in patient populations for validation. As assessment tools become more reliable and validated, we can better rely on them to assess outcomes of interest in therapeutic clinical trials, long term observational registries, and to a certain extent, in clinical practice.
Joachim Sieper, in Rheumatology Sixth Edition , Enrolled participants were followed during adalimumab therapy. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled. Drug Information available for: Adalimumab. FDA Resources. Outcome Measures.
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Extraspinal manifestations enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease IBD were assessed by investigators and reported on the basis of their clinical evaluation and participant records. Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
The BAS-G was a participant-reported instrument with two items. Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity.
The assessment of ankylosing spondylitis in clinical practice
Morning stiffness was a participant-reported assessment. Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours.
The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. No contraindications for anti-tumor necrosis factors TNF therapy. Exclusion Criteria: 1. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)
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